Suprax, 100 mg/5 ml 60 ml

Pharmacological action – broad spectrum antibacterial, bactericidal.

Pharmacodynamics

Inhibits the synthesis of the cell membrane of the pathogen. Cefixime is resistant to beta-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro cefixime is active against Gram-positive bacteria: Streptococcus agalactiae; Gram-negative bacteria: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp, Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

In vitro and in clinical practice cefixime is active against Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; Gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, E. coli, Proteus mirabilis, Neisseria gonorrhoeae.

Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

In oral administration the bioavailability of cefixime is 40-50% regardless of meals, but Cmax of cefixime in serum is reached 0.8 hours faster when the drug is taken with food.

When taking the drug in the form of capsules in a dose of 200 mg, Cmax in the serum is reached after 4 hours and is 2 mcg/ml, when taking in a dose of 400 mg – 3.5 mcg/ml. When taking the preparation in suspension form in a dose of 200 mg, Cmax in serum is reached after 4 hours and is 2.8 µg/ml, when taken in a dose of 400 mg – 4.4 µg/ml. Binding with plasma proteins, mainly with albumin, is 65%.

About 50% of the dose is excreted unchanged in the urine within 24 hours, about 10% of the dose is excreted in the bile. T1/2 depends on the dose and is 3-4 hours.

In patients with kidney dysfunction in creatinine Cl 20-40 ml/min T1/2 is increased to 6.4 hours, in creatinine Cl 5-10 ml/min – to 11.5 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

– pharyngitis;

– tonsillitis;

– sinusitis;

– acute and chronic bronchitis;

– otitis media;

– uncomplicated urinary tract infections;

– uncomplicated gonorrhea.

Pharmacological effect

Pharmacological action – broad spectrum antibacterial, bactericidal.

Pharmacodynamics

Inhibits the synthesis of the pathogen’s cell membrane. Cefixime is resistant to beta-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro, cefixime is active against gram-positive bacteria: Streptococcus agalactiae; gram-negative bacteria: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

In vitro and in clinical practice, cefixime is active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, E.coli, Proteus mirabilis, Neisseria gonorrhoeae.

Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp. are resistant to the drug. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

When taken orally, the bioavailability of cefixime is 40–50%, regardless of food intake, however, the Cmax of cefixime in serum is achieved 0.8 hours faster when taking the drug with food.

When taking the drug in capsule form at a dose of 200 mg, Cmax in serum is achieved after 4 hours and is 2 mcg/ml, when taken at a dose of 400 mg – 3.5 mcg/ml. When taking the drug in the form of a suspension at a dose of 200 mg, Cmax in serum is achieved after 4 hours and is 2.8 mcg/ml, when taken at a dose of 400 mg – 4.4 mcg/ml. Binding to plasma proteins, mainly albumin, is 65%.

About 50% of the dose is excreted unchanged in the urine within 24 hours, about 10% of the dose is excreted in bile. T1/2 depends on the dose and is 3–4 hours.

In patients with impaired renal function, with a creatinine Cl of 20-40 ml/min, T1/2 increases to 6.4 hours, with a creatinine Cl of 5-10 ml/min – up to 11.5 hours.

Special instructions

Patients with a history of allergic reactions to penicillins may have increased sensitivity to cephalosporin antibiotics.

Long-term use of the drug may disrupt the normal intestinal microflora, which can lead to the growth of Clostridium difficile, causing severe diarrhea and pseudomembranous colitis. During treatment, a positive direct Coombs test and a false positive urine test for glucose are possible.

Active ingredient

Cefixime

Composition

5 ml of ready-made suspension: – cefixime 100 mg

Excipients:

sodium benzoate,

sucrose,

yellow resin,

strawberry flavor.

Pregnancy

Use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

With caution: old age;

chronic renal failure;

pseudomembranous colitis (history);

children’s age (up to 6 months).

Side Effects

Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever, erythema multiforme, toxic epidermal necrolysis, anaphylactic shock.

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, dysbiosis, liver dysfunction (increased activity of liver transaminases, alkaline phosphatase, hyperbilirubinemia, jaundice), gastrointestinal candidiasis; rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic organs: leukopenia, neutropenia, thrombocytopenia, hemolytic anemia.

From the urinary system: interstitial nephritis.

From the nervous system: dizziness, headache.

Interaction

Blockers of tubular secretion (allopurinol, diuretics, etc.) delay the excretion of cefixime by the kidneys, which can lead to increased toxicity.

Reduces the prothrombin index, enhances the effect of indirect anticoagulants.

Antacids containing magnesium or aluminum hydroxide slow down the absorption of the drug.

Overdose

Symptoms: increased risk of adverse reactions.

Treatment: gastric lavage; symptomatic and supportive therapy, which, if necessary, includes the use of antihistamines, corticosteroids, pressor amines, oxygen therapy, transfusion of infusion solutions, mechanical ventilation. It is not excreted in significant quantities by hemo- or peritoneal dialysis.

Storage conditions

At 15–25 °C

Shelf life

3 years

Manufacturer

ACS Dobfar S.p.A., Italy